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English to Chinese: Parecoxib China Feedback Safety Data 2020 Recurring Ad Hoc Safety Analysis-Report General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - English 1.药品名称 BEXTRA IM/IV、特耐、PRO-BEXTRA、PRO-VALDENE、RAYZON、VALDYNE、VALDUREIM 2.定性和定量组成 40 mg 瓶装：各小瓶含有 40mg 帕瑞昔布（以 42.36mg 帕瑞昔布钠形式存在），采用 2ml 溶剂复溶。复溶后，帕瑞昔布的最终浓度为 20 mg/ml。 20 mg 瓶装：各小瓶含有 20 mg 帕瑞昔布（以 21.18 mg 帕瑞昔布钠形式存在），采用 1 ml 溶剂复溶。复溶后，帕瑞昔布的最终浓度为 20 mg/ml。 3.剂型注射用粉针剂粉剂和注射液溶剂 4.临床特性 4.1.治疗适应症帕瑞昔布适用于治疗急性疼痛[1]，术前（先发镇痛）以预防或减少术后疼痛，或与阿片类镇痛药同时使用以减少对阿片类药物的需求。 4.2.用法用量帕瑞昔布可单次或多次静脉或肌内注射，采用常规剂量或按需给药。开始治疗后，应根据患者的反应调整剂量。帕瑞昔布临床研究中使用的最长治疗时间为 7 天[1]。帕瑞昔布仅适用于需要肠外治疗且替代口服治疗无法获得类似获益的患者。建议患者在出现临床指征后尽快转换为替代性口服治疗[46]。因为环氧合酶-2（COX-2）特定抑制剂的心血管(CV)风险会随剂量升高和用药时间延长而增加，所以应尽可能缩短用药时间和使用每日最低有效剂量。然而，尚未评估这些研究结果与帕瑞昔布在术后环境中短期使用的相关性[46]。  急性疼痛的治疗：治疗急性疼痛的推荐单剂量或初始剂量为 40 mg，IV 或 IM，然后根据需要进行 20 mg 或 40 mg 给药、每 6 至 12 小时一次，每日最大剂量为 80 mg。可直接进行快速静脉推注，或通过已有静脉通路给药。肌内注射应选择深部肌肉缓慢推注。  预防或减少术后疼痛：推荐剂量为 40 mg，在手术切口前 30-45 分钟静脉或肌内注射（但最好是静脉注射）为了获得足够的镇痛效果，可能需要在手术后继续使用帕瑞昔布治疗。  与阿片类镇痛药联合用药：阿片类镇痛药可以与帕瑞昔布同时应用，本品使用剂量参见上文。在临床试验中，当与帕瑞昔布共同给药时，阿片类药物的日需要量显著降低（20%-40%）。在使用阿片类药物之前给予帕瑞昔布，可获得最佳效果。在所有临床评估中，帕瑞昔布是固定间隔时间给药，而阿片类药物则是按需给药(PRN)[63]。老年患者：一般不需要调整剂量。但是，对于体重低于 50kg 的老年患者，建议将本品的初始剂量减少 50%，在体重低于 50kg 的老年患者中，每日最高剂量应减至 40mg。肝功能损害：不需对轻度肝功能损害患者（Child-Pugh A 类）进行剂量调整。中度肝功能损害的患者（Child-Pugh B 类）使用本品时，应以最低推荐剂量开始治疗[12]。尚未研究重度肝功能损害（Child-Pugh C 类）患者。不建议重度肝功能损害患者使用帕瑞昔布。肾功能损害：对于重度肾功能损害（肌酐清除率：3 天帕瑞昔布治疗的 3 项试验的数据进行合并和分析，358 名患者接受 > 3 天帕瑞昔布治疗，318名患者接受 > 3 天安慰剂治疗。两组人口统计数据相似。帕瑞昔布和安慰剂治疗的平均（SD）持续时间分别为4.1（0.4）天和4.2（0.5）天，帕瑞昔布和安慰剂治疗的持续时间范围分别为4至7天和4至9天。接受 4至7 天帕瑞考昔治疗（中位持续 4 天）的患者中，在治疗第 3 天后 AE 的发生率类似于安慰剂组[74]。对阿片类药物用量的降低作用[55,56,63] 与单独使用阿片类药物相比，推荐剂量的帕瑞昔布显著降低阿片类药物的摄入量和患者报告的阿片类药物相关不良反应（疲劳、嗜睡、意识模糊、注意力不集中、头晕、恶心、便秘、排尿困难、瘙痒、干呕/呕吐），增加了疼痛的缓解程度。在一项安慰剂对照、骨科及普外科手术的研究（n=1050）中，患者接受起始剂量 40 mg、随后 20 mg，一日两次，至少 72h 治疗，并接受包括患者自控阿片类药物（静脉硫酸吗啡）作为辅助治疗的标准化处理。使用本品治疗的患者在第 2 天和第 3 天时阿片类药物用量分别减少了 7.2 mg 和 2.8 mg（分别减少了 37% 和 28%）。阿片类药物用量减少的同时，患者自发报告阿片类相关症状不适有了显著减少；且和单独应用阿片类药物相比，联合应用帕瑞昔布可获得更多的疼痛缓解。其他手术模型的研究也可观察到类似结果。血小板[57,58,59] 在临床试验研究中，给予青年（18-55 岁）与老年（65-83 岁）受试者单次和多次帕瑞昔布 20 mg 或 40 mg、一天两次，最多 7 天，帕瑞昔布对血小板聚集或出血没有影响。与之相比，酮咯酸 15mg 和 30 mg 单次给药，或治疗 5 天后，显著减少血小板聚集并显著增加出血时间。与安慰剂相比，帕瑞昔布（40 mg，每天两次）对阿司匹林介导的血小板功能抑制无临床显著影响，并且未改变肝素对aPTT 或血小板的药效学作用。胃肠道研究[60,61,62] 在为期 7 天的短期临床研究中，在使用本品的青年与老年（≥65 岁）健康受试者中，内窥镜下胃及十二指肠溃疡和粘膜糜烂的发生率为 5%至21%。发生率高于安慰剂组（5%至12%），然而显著低于 NSAID 组（66%至90%）。 CABG 术后安全性研究 [53,54] 两项安慰剂对照安全性研究（患者接受帕瑞昔布钠治疗，持续至少3天，然后转换为口服Valdecoxib治疗，持续10至14天）中，常规不良事件报告除外，还对独立专家委员会裁定的预先指定的事件类别进行了研究。所有受试者在治疗期间均接受标准止痛护理。受试者在随机分组前及两项 CABG 手术研究过程中均服用低剂量乙酰水杨酸。第一项 CABG 手术研究是为期 14 天的双盲安慰剂对照研究，受试者首先静脉注射帕瑞昔布钠（40 mg，每天两次）至少 3 天，随后接受Valdecoxib（40 mg, 每天两次，帕瑞昔布钠/Valdecoxib组，n=311）或安慰剂/安慰剂(n=151)给药。对 9 项预先指定的不良事件类别（包括心血管血栓栓塞事件、心包炎、新发充血性心脏衰竭或恶化、肾衰/肾功能不全、上消化道溃疡、非胃肠道大出血、感染、非感染性肺部并发症及死亡）进行评估。静注给药期间和全部研究过程中，帕瑞昔布/Valdecoxib组心血管/血栓栓塞事件（包括心肌梗死、心肌缺血、脑血管意外、深度静脉栓塞以及肺栓塞）的发生率均显著(p	Translation - Chinese 1. NAME OF THE MEDICINAL PRODUCT BEXTRA IM/IV, DYNASTAT, PRO-BEXTRA, PRO-VALDENE, RAYZON, VALDYNE, VALDUREIM 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 40 mg vial: Each vial contains 40 mg parecoxib (present as 42.36 mg parecoxib sodium) for reconstitution with 2 ml of solvent. After reconstitution, the final concentration of parecoxib is 20 mg/ml. 20 mg vial: Each vial contains 20 mg parecoxib (present as 21.18 mg parecoxib sodium) for reconstitution with 1 ml of solvent. After reconstitution, the final concentration of parecoxib is 20 mg/ml. 3. PHARMACEUTICAL FORM Powder for solution for injection Powder and solvent for solution for injection 4. CLINICAL PARTICULARS 4.1. Therapeutic indications Parecoxib is indicated for management of acute pain [1], pre-operatively (pre-emptive analgesia) to prevent or reduce post-operative pain, or concomitantly with opioid analgesics to reduce opioid requirements. 4.2. Posology and method of administration Parecoxib may be administered as single or multiple IV or IM doses on a regular or as needed schedule. After initiation of therapy, dosage should be adjusted based on patient response. Clinical studies with parecoxib were conducted using up to 7 days of treatment.[1] Parecoxib is only indicated for patients with a need for parenteral therapy and for whom a similar benefit could not be obtained from alternative oral therapy. It is recommended that patients be transitioned to alternative oral therapy as soon as clinically indicated.[46] As the cardiovascular (CV) risk of cyclooxygenase-2 (COX-2) specific inhibitors may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. However, the relevance of these findings for the short- term use of parecoxib in the postoperative setting has not been evaluated.[46]  Management of Acute Pain: The recommended single or initial dose for treatment of acute pain is 40 mg, administered either IV or IM, followed by 20 mg or 40 mg every 6 to 12 hours, as required, up to a maximum daily dosage of 80 mg. The IV bolus injection may be given directly into a vein or into an existing IV line. The IM injection should be given slowly and deeply into the muscle.  Prevention or Reduction of Post-operative Pain: The recommended dose is 40 mg administered IV or IM (but preferably IV) 30 to 45 minutes prior to surgical incision. Continued medication with parecoxib post-operatively may be needed for adequate analgesic effect.  Concomitant Use with Opioid Analgesics: Opioid analgesics can be used concurrently with parecoxib, dosing as described above. In clinical trials, the daily requirement for opioids was significantly reduced (20%-40%) when coadministered with parecoxib. An optimal effect is achieved when parecoxib is given prior to opioid administration. In all clinical assessments parecoxib was administered at a fixed time interval whereas the opioids were administered on as needed basis (PRN).[63] Elderly: No dosage adjustment is generally necessary. However, for elderly patients weighing less than 50 kg, it is advisable to reduce the initial dose of parecoxib by 50%. The maximum daily dose should be reduced to 40 mg in elderly patients weighing less than 50 kg. Hepatic Impairment: No dosage adjustment is necessary in patients with mild hepatic impairment (Child-Pugh Class A). Treatment with parecoxib should be initiated at the lowest recommended dose in patients with moderate hepatic impairment (Child-Pugh Class B).[12] Patients with severe hepatic impairment (Child-Pugh Class C) have not been studied. The use of parecoxib in these patients is not recommended. Renal Impairment: In patients with severe renal impairment (creatinine clearance
Chinese to English: 预灌封注射器组合件（带注射针） General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - Chinese YBB00112004 ·2015 预灌封注射器组合件（带注射针） Yuguanfeng Zhusheqi Zuhejian（Daizhushezhen Assemblages for Prefilled Syringes（with Stainless Steel Needles) 本标准适用于预灌封注射器组合件（带注射针）。组合件由玻璃针管、橡胶活塞、不锈钢注射针、针头护帽和推杆组成。外观】取本品适量，在自然光线明亮处，正视目测。玻璃针管管套应无裂缝或裂痕，卷边应无变形；锥头、卷边应无裂缝或断裂；针管外表面应无斑点、污点、擦痕；无影响使用的印刷缺陷；针应无分离、无颠倒、无阻塞；针与针头护帽不得分离。玻璃针管】应符合预灌封注射器用硼硅玻璃针管(YBB00062004-2015)的要求。橡胶活塞】应符合预灌封注射器用氯化丁基胶活塞（YBB00072004-2015）或预灌封注射器用溴化丁基橡胶活塞（YBBm082004-2015）的要求。不锈钢注射针】应符合预灌封注射器用不锈钢注射针的（YBB00092004-2015）的要求。针头护帽】应符合预灌封注射器用聚异戊二烯橡胶针头护帽（YBB00102004-2015）的要求。针与针座的连接力】取本品适量，将注射器固定在试验机上，以100mm/min±5mm/min 速度，在不得小于22N的拉力下，进行注射针的拉拔试验。不锈钢注射针与玻璃针管的针座间不得松动或分离。针头护帽的拔出力】，取本品适量，将针头护帽和注射针管固定在试验机上、下夹具内，试验速度为100mm/min±5mm/min。针头护帽的拔出力应在4.0-45.0N之间。活塞与推杆的配合性】（仅适用于带螺纹的活塞）取本品适量，将推杆和活塞相连接，把活塞完全插入经硅油润滑过并装满一半水的预灌封注射器内，排除空气，在注射器上插上针头护帽，缓慢向后撤出约3mm的距离。推杆应保持稳定，不应与活塞分离。【活塞润滑性】取本品适量，将活塞插入硅油润滑的注射器针管中，用推杆将活塞推入整个注射器针中。推杆活塞应平滑的移动，不应有突然的停顿。【活塞滑动性能】取本品适量，将推杆活塞放入硅油润滑的针管中，以100mm/min± 5 mm/min的速度推动推杆。活塞滑动的启始力和活塞持续滑动的持续力应符合表1的规定。表1滑动性能规格（标示容量，ml）启始力（Fmax, N）持续力（Fmax, N） V	Translation - English YBB00112004 -2015 Yuguanfeng Zhusheqi Zuhejian（Daizhushezhen） Assemblages for Prefilled Syringe Assemblage（with Stainless Steel Needles) This standard applies to prefilled syringe assemblages (with stainless steel needles), which consist of a glass syringe tube, a rubber piston, a stainless steel needle, a needle cap and a pusher. Appearance: When inspected by bare eyes under bright natural light, the glass syringe tube cover should be free of cracks. The coil edges and the cone head should exhibit no deformation or fractures. Besides, the outer surface of the tube should exhibit no spots, stains, scratches or any unclear printing that may affect its use. The needle should exhibit no separation and obstruction, and it should position correctly without being upside down. The needle and its cap should not be separated. Glass syringe tube: Must comply with the requirements for boron-silicon glass tubes for prefilled syringes (YBB00062004-2015). Rubber pistons: Must comply with the requirements for butyl chloride rubber pistons for prefilled syringes (YBB00072004-2015) or brominated butyl rubber pistons for prefilled syringes (YBBM082004-2015). Stainless steel needles: Must comply with the requirements for stainless steel injection needles for prefilled syringes (YBB00092004-2015). Needle cap: Must comply with the requirements of polyheteride rubber needle cap for prefilled syringes (YBB00102004-2015). The connection force between the needle and its seat: Locate and fix the syringe on the test machine, and perform needle pulling tests at a speed of 100±5mm/min and a pull force of not less than 22N. The stainless steel needle must not be loosened or separated from its pin seat. The pull-out force of needle caps: Locate and fix the needle cap and the tube on the test machine, and perform pull-out tests at a speed of 100±5mm/min. The pull-out force should lie between 4.0-45.0N.The piston-pusher fitness (only for threaded pistons): Connect the pusher to the piston, and fully insert the piston into a prefilled syringe lubricated by silicone oil and half-filled with water to eject air. Put the needle cap on the syringe, and slowly withdraw the piston back for about 3mm. The pusher should remain stable and not separated from the piston.Piston Lubricity: Insert the piston into the syringe tube lubricated by silicone oil, and push the piston fully inside the syringe tube with a push rod. The piston should move smoothly without sudden resistance. Piston Sliding: Insert the piston into the syringe tube lubricated by silicone oil, and push the piston inside at a speed of 100±5 mm/min. The start and continuous forces for piston sliding should comply with Table 1. Table 1 Sliding Performance Specifications Tube Volume (marked capacity, ml) Start Force (Fmax, N) Continuous Force (Fmax, N) V

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